Abstract
BackgroundSafe, highly curative, short course, direct acting antiviral (DAA) therapies are now available to treat chronic hepatitis C. DAA therapy is freely available to all adults chronically infected with the hepatitis C virus (HCV) in Australia. If left untreated, hepatitis C may lead to progressive hepatic fibrosis, cirrhosis and hepatocellular carcinoma. Australia is committed to eliminating hepatitis as a public health threat by 2030 set by the World Health Organization. However, since the introduction of funded DAA treatment, uptake has been suboptimal. Australia needs improved strategies for testing, treatment uptake and treatment completion to address the persisting hepatitis C public health problem. PLATINUM C is a HCV treatment registry and research platform for assessing the comparative effectiveness of alternative interventions for achieving virological cure.MethodsPLATINUM C will prospectively enrol people with active HCV infection confirmed by recent detection of HCV ribonucleic acid (RNA) in blood. Those enrolled will agree to allow standardised collection of demographic, lifestyle, treatment, virological outcome and other relevant clinical data to better inform the future management of HCV infection. The primary outcome is virological cure evidenced by sustained virological response (SVR), which is defined as a negative HCV PCR result 6 to 18 months after initial prescription of DAA therapy and no less than 12 weeks after the completion of treatment. Study participants will be invited to opt-in to medication adherence monitoring and quality of life assessments using validated self-reported instruments (EQ-5D-5L).DiscussionPLATINUM C is a treatment registry and platform for nesting pragmatic trials. Data collected will inform the design, development and implementation of pragmatic trials. The digital infrastructure, study procedures and governing systems established by the registry will allow PLATINUM C to support a wider research platform in the management of hepatitis C in primary care.Trial registrationThe trial is registered with the Australia and New Zealand Clinical Trials Register (ACTRN12619000023156). Date of registration: 10/01/2019.
Highlights
Safe, highly curative, short course, direct acting antiviral (DAA) therapies are available to treat chronic hepatitis C
With the recent development of direct acting antiviral (DAA) therapy, hepatitis C virus (HCV) infection is curable in the majority of those infected with drugs that are safe, well tolerated, and highly effective
From March 2016, all adults chronically infected with HCV in Australia have been eligible for treatment with DAA funded by the Government under the Pharmaceutical Benefit Scheme (PBS)
Summary
Highly curative, short course, direct acting antiviral (DAA) therapies are available to treat chronic hepatitis C. Hepatitis C in Australia Hepatitis C virus (HCV) infection is a major public health issue in Australia and other countries due to the substantial morbidity associated with chronic infection. It is estimated 71 million people are living with HCV worldwide including over 180,000 in Australia [1, 2]. Those chronically infected with HCV, if left untreated, are at risk of progressive hepatic fibrosis, cirrhosis and hepatocellular carcinoma. Prescribing the newly licenced DAAs was complicated by the number of drugs available and treatment guidelines that factor in virus genotype, cirrhosis status, previous treatment status, drug-drug interactions and presence of comorbidities
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